Label: ANTI-BACTERIAL HAND- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 6, 2011

If you are a consumer or patient please visit this version.

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% w/w

  • PURPOSE

    Anti-bacterial

  • USE

    • To decrease bacteria on the skin and clean hands.
    • Recommended for repeated use.
  • WARNINGS

    For external use only. Flammable, keep away from fire or flame.

    Keep out of reach of children.

    If accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Do not get into eyes.

    If contact occurs, rinse thoroughly with water.

    Discontinue use

    if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

  • DIRECTIONS

    • Apply to hands until thoroughly wet.
    • Rub vigorously until dry.
    • Supervise children in the use of this product.
  • Inactive Ingredients

    Sweet Cherry Blossom

    Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5

    Warm Vanilla Sugar

    Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5, Blue 1

    Vanilla Bean Noel

    Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Retinyl Palmitate, Ultramarine, Red 33, Yellow 5, Blue 1

    Merry Berry

    Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Retinyl Palmitate, Ultramarine, Red 33, Yellow 5, Blue 1

    Peppermint Twist

    Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Retinyl Palmitate, Ultramarine, Red 33, Yellow 5, Blue 1

    Kiss and Tell

    Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5

    Spring Fling

    Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Chromium Hydroxide Green, Retinyl Palmitate, Yellow 5, Blue 1

    Sweet Cherry Blossom

    Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5

    Spring Blossom

    Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Ultramarine, Retinyl Palmitate, Yellow 5, Blue 1

  • QUESTIONS?

    1-800-FDA-1088

  • SPL UNCLASSIFIED SECTION

    Made in China

    Distributed by Jets, Sets & Elephants Beauty Corp.

    For ShopKo Stores Operating Co., LLC

    Green Bay, WI 54307, U.S.A

    ©2010 ShopKo Stores Operating Co., LLC

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath-body-etc®

    Sweet Cherry Blossom

    anti-bacterial

    hand gel

    PARABEN FREE

    contains aloe vera and

    vitamins A & E

    1 fl oz

    Bottle Label

    Sweet Cherry Blossom Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath-body-etc®

    Warm Vanilla Sugar

    anti-bacterial

    hand gel

    PARABEN FREE

    contains aloe vera and

    vitamins A & E

    1 fl oz

    Bottle Label

    Warm Vanilla Sugar Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath-body-etc®

    Vanilla Bean Noel

    anti-bacterial

    hand gel

    1 fl oz

    principal display panel - vanilla bean noel bottle label

    Vanilla Bean Noel Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath-body-etc®

    Merry Berry

    anti-bacterial

    hand gel

    1 fl oz

    principal display panel - merry berry bottle label

    Merry Berry Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath-body-etc®

    Peppermint Twist

    anti-bacterial

    hand gel

    1 fl oz

    principal display panel - peppermint twist bottle label

    Peppermint Twist Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath-body-etc®

    Kiss and tell

    anti-bacterial

    hand gel

    1 fl oz

    Bottle Label

    Kiss and tell Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath-body-etc®

    Spring fling

    anti-bacterial

    hand gel

    1 fl oz

    Bottle Label

    Spring fling Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath-body-etc®

    Sweet cherry blossom

    anti-bacterial

    hand gel

    1 fl oz

    Bottle Label

    Sweet cherry blossom Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath-body-etc®

    Spring Blossom

    anti-bacterial

    hand gel

    1 fl oz

    Bottle Label

    Spring Blossom Bottle Label

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL HAND 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.335 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-270-0029.574 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/11/2011
    ANTI-BACTERIAL HAND 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-271
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.335 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-271-0029.574 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/11/2011
    ANTI-BACTERIAL HAND 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-272
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.335 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-272-0029.574 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/10/2011
    ANTI-BACTERIAL HAND 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-273
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.335 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-273-0029.574 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/10/2011
    ANTI-BACTERIAL HAND 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-274
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.335 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-274-0029.574 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/10/2011
    ANTI-BACTERIAL HAND 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-275
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.335 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-275-0029.574 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/15/2011
    ANTI-BACTERIAL HAND 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-276
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.335 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-276-0029.574 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/15/2011
    ANTI-BACTERIAL HAND 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-277
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.335 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-277-0029.574 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/15/2011
    ANTI-BACTERIAL HAND 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-278
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.335 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-278-0029.574 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/15/2011
    Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gold Orient International Limited679905914MANUFACTURE(50988-270, 50988-271, 50988-272, 50988-273, 50988-274, 50988-275, 50988-276, 50988-277, 50988-278)
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